recently released on third report of the Italian Medicines Agency (AIFA) on surveillance vaccines against Covid-19 referring to the period 27 December 2020-26 March 2021 and products Pfizer, AstraZeneca and Moderna.
The most frequent reactions
The total reports of adverse events are 510 for every 100 thousand doses administered. They mainly concern Pfizer (81%), which was the most used, and only to a lesser extent AstraZeneca (17%) and Moderna (2%). The reporting rate (ratio of the number of reactions to the doses administered) of 535 events for 100 thousand doses for Pfizer, 227 for Moderna and 477 for AstraZeneca.
For all vaccines the most reported adverse events in order of frequency are: temperature, injection site pain, fatigue and chills, muscle and joint pain, headache and paraesthesia, nausea and diarrhea, with little statistical difference between the three products. Mostly they arise on the same day as vaccination or the day after.
Women have a higher reporting rate (645 versus 299 for men).
The older population (after 60 years) has a lower predisposition to the onset of side effects.
The severe and rare cases
These are non-serious events in 92.7% of cases and serious in 7.1% of the total. Reporting rates for serious events are 33 per 100,000 administrations for Pfizer, 22 for Moderna and 50 for AstraZeneca. Among the serious reactions for Pfizer and Moderna we have: high fever, severe headache, muscle / joint pain and weakness.
For Pfizer less frequently, allergic-type reactions, lymphadenopathy, paraesthesia, tachycardia, hypertensive crisis and facial paralysis are reported.
With AstraZeneca high fever, tremor, dizziness, syncope, drowsiness, generalized pain.
Overall, there are 102 reports with a death outcome, the causes of which are under investigation. There are 1.1 cases per 100 thousand doses with an average age of 81.4 years. No deaths have been reported as a result of anaphylactic shock or allergic reactions, while cardiovascular events are often reported in patients with a clinical history of previous pathologies. The causal link can be correlated in a single report.
Johnson & Johnson fewer reports
The fourth vaccine expected in Europe and Italy, but temporarily not yet administered, that of Johnson & Johnson, according to the analysis of Centers for Disease Control and Prevention Usa carries side effects in line with those experienced by people who received Pfizer and Moderna, but in a fewer numbers (in clinical trials). There have also been fewer cases of allergic reactions. by a vaccine still little used compared to the others, because in the US it received authorization on February 27, but was suspended on April 13 for the investigation that involved 6 cases of rare thrombosis out of 6.8 million doses administered.
The atypical thrombosis
Just the atypical thrombosis are one of the possible serious side effects of the AstraZeneca vaccine. In Europe there were 222 cases out of 34 million injected doses, in Italy 11 of which 4 were fatal. The European Medicines Agency (EMA) has linked AstraZeneca’s vaccine with rare thrombosis by talking about a strong causal link. The frequency estimated at approx 1 case in 100 thousand. The agency did not identify specific risk factors such as age or gender, but the analyzes continue.
Allergic reactions
A particular recommendation concerns the allergic reactions: US data on mRNA vaccines reports 4.7 anaphylaxis per million doses for Pfizer and 2.5 cases per million for Moderna. Almost entirely in women and in people with a history of allergies. The main defendant appears to be the polyethylene glycol (PEG), one of the components of mRNA vaccines (the AstraZeneca viral vector vaccine does not contain it). The danger of allergic reactions, although higher than that of the flu, very low. In Italy, the management of people with allergic risk does not exclude vaccination, which will be carried out in the hospital, in the presence of an anesthetist, or in an outpatient clinic with trained personnel and with prolonged observation up to one hour after inoculation.
April 18, 2021 (change April 18, 2021 | 07:52)
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